Clinical Pharmacology Strategy

First-in-human Trials and Going Too FAAH from the Sentry

Graham Scott

Many people in the UK and elsewhere are currently remembering where they were and what they were doing on the day that Diana Princess of Wales died: August 31st marks 20 years since that fateful day. For Clinical Pharmacologists, we may well remember where we were when we heard the news that six volunteers were […]

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Topics: Clinical Pharmacology Strategy

Using Sampling “Windows” for PK Blood Samples

Nathan Teuscher

One of the most common questions posed by clinical operations experts when including pharmacokinetic sampling in a clinical trial is the following: “What is the time window we should allow for each blood sample?” My answer is always the same: “Don’t include any window.” I am almost always met with a confused look. The confusion is […]

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Topics: PK/PD Modeling & Simulation

What is a Loading Dose?

Nathan Teuscher

Drug therapy in chronic disease situations requires systemic drug levels to reach target steady-state levels for maximum safety and efficacy. The time it takes for a drug to reach steady-state is a function of the elimination half-life of the drug. The following table illustrates how long it will take to achieve steady-state relative to the […]

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Topics: PK/PD Modeling & Simulation
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